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The Food and Drug Administration on February 16-18, 2005 Held an Advisory Committee Meeting to Discuss the Cardiovascular Risk P

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The Food and Drug Administration on February 16-18, 2005 Held an Advisory Committee Meeting to Discuss the Cardiovascular Risk P The Food and Drug Administration on February 16-18, 2005 held an advisory committee meeting to discuss the cardiovascular risk posed by painkillers known as Cox- 2 inhibitors, which include Celebrex, Bextra and Vioxx. The former two drugs are manufactured by Pfizer. The latter is manufactured by Merck. Novartis also has a Cox-2 inhibitor in its pipeline. At the end of the hearing, the FDA advisory panel voted to keep all three on the market, though with heightened warnings about the dangers posed by this class of drugs. At the request of the New York Times, the Center for Science in the Public Interest evaluated the 32 scientific experts chosen by the FDA to evaluate these drugs. The CSPI research uncovered affiliations between 10 of the scientists that served on the committee and the three manufacturers of Cox-2 inhibitors. This would appear to be a direct violation of the Federal Advisory Committee Act, which prohibits scientists with direct conflicts of interest from serving on panels offering advise to federal regulatory agencies. Another 17 scientists had other ties to drug manufacturers, though not the three with products under consideration at the meeting. According to a New York Times analysis of the votes, the advisory committee would have voted against Bextra and Vioxx staying on the market had scientists with conflicts of interest been excluded from the vote. Here is the CSPI analysis of the FDA Advisory Panel: CSPI found ten (10) physician/researchers with direct ties to Pfizer, Merck or Novartis (including G.D. Searle and Pharmacia, which are now part of Pfizer). They were: Total: 10 Steven Abramson, M.D., Professor and Chairman, Division of Rheumatology, NYU School of Medicine, New York. Has an interest in Merck. (“Food and Drug Administration Center for Drug Evaluation and Research,” Congressional Hearing Transcripts, 7/20/99) Received speaker's honoraria or consulting fees from Pfizer, Amgen, Novartis, and Pharmacia. (http://www.freecme.com/gcourse_view.php?course_id=1824; accessed 2/22/05) Consultant for Searle, and a member of the Speakers Bureau for Pfizer. Received an unrestricted educational grant from Pharmacia. (http://www.docguide.com/news/content.nsf/news/2A345DDE45B8C851852569AE004 B52DC; accessed 2/23/05) Joan M. Bathon, M.D. Professor of Medicine, Division of Rheumatology, Department of Medicine, Johns Hopkins University. Received consultancies and/or honoraria from Centocor, Inc., a subsidiary of Johnson & Johnson, totaling less than $10,000 per year. ( Arthritis Rheum. 2004;50:3432-43.) Received ad hoc consultant fees and support for this research from Immunex. (Arthritis Rheum. 2002 Jun;46(6):1443-50.) Received support for research on etanercept and methotrexate in patients with early rheumatoid arthritis from Immunex, Inc. (N Engl J Med. 2000 Nov 30;343(22):1586-93.) Consultant for: National Advisory Board CTLA4-IG Project, Bristol Myers Squibb, 2000; International Advisory Board, Anti-TNF Project, Centocor, 2000; National Advisory Board, Anti-TNF Project, Knoll Pharmaceuticals, 2000; National Advisory Board, Anti-TNF Project, Immunex and Wyeth, 1998-99; National Advisory Board, Cox-2 Project, Searle, 1998- 2000; Consultant, Bradykinin receptor antagonist project, Fournier Pharmaceuticals, 1996; Consultant, Anti-inflammatory initiative, Procter & Gamble. (http://www.fda.gov/cder/audiences/acspage/CVs/Bathon,%20Joan%20M..pdf; accessed 2/23/05) John J. Cush, M.D., Article on concomitant leflunomide therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate listed potential conflicts of interest due to consultancies, honoraria and grants received. (Ann Intern Med. 2002 Nov 5;137(9):726-33.) Consultant: Abbott, Amgen, Wyeth, Centocor, Pfizer, Regeneron; Disclosure: Current Investigator: Abbott, Amgen, Biogen Idec, Pfizer. (J Rheumatol. 2005 Feb;32(2):203-7.) ) Received grants from Abbott, Amgen/Weiss, Aventis, Centocor, IDEC/Genentech, Isis Pharmaceuticals. (http://www.fbhc.org/cme/abt04202/index.cfm; accessed 2/23/05) Dr. Cush is a member of The Cadeuceus Group, LLC. (http://www.fbhc.org/cme/abt04202/index.cfm; accessed 2/23/05) Robert H. Dworkin, Ph.D., Professor of Mathematics/Statistics and Public Health, Boston University, MA. Member of the Steering Committee of the Pfizer Medical and Academic Partnerships in Pain Medicine. (http://shingles.mgh.harvard.edu/dworkin.htm; accessed 2/22/05) Received research support, consulting fees, or speakers bureau honoraria in the past year from Abbott Laboratories, Allergan, AstraZeneca, Bristol- Myers Squibb, Elan Pharmaceuticals, Eli Lilly and Co, Endo Pharmaceuticals, King Pharmaceuticals, Johnson and Johnson, NeurogesX, Novartis Pharmaceuticals, Ortho- McNeil Pharmaceutical, Pfizer, Purdue Pharma, Quigley Pharma, Reliant Pharmaceuticals, and UCB Pharma. (http://64.233.161.104/search?q=cache:9Znwic8zFR4J:www.guideline.gov/summary/su mmary.aspx%3Fview_id%3D1%26doc_id%3D4671+%22John+T.+Farrar%22+Merck+ OR+GlaxoSmithKline+OR+AstraZeneca+OR+Pfizer+OR+Novartis+OR+Aventis+OR+ Squibb&hl=en; accessed 2/23/05) John T. Farrar, M.D., Senior Scholar, University of Pennsylvania, Center for Clinical Epidemiology and Biostatistics, Philadelphia. Received research or grant support from Pfizer, Cephalon, Smithkline Beecham, Knoll, and Searle; served as a consultant for Abbott Laboratories, Alza, Endo Pharmaceuticals, UCB Pharma, and Faulding; and served on the speakers bureau of Purdue Frederick. (http://64.233.161.104/search?q=cache:9Znwic8zFR4J:www.guideline.gov/summary/su mmary.aspx%3Fview_id%3D1%26doc_id%3D4671+%22John+T.+Farrar%22+Merck+ OR+GlaxoSmithKline+OR+AstraZeneca+OR+Pfizer+OR+Novartis+OR+Aventis+OR+ Squibb&hl=en; accessed 2/23/05) J. Michael Finley, D.O., Received funding for the Zometa Trial from Novartis Pharmaceuticals in 2000. (http://www.fda.gov/cder/audiences/acspage/CVs/Finley,%20J.%20Michael.pdf; accessed 2/23/05) Allan Gibofsky, M.D., J.D., Independent advisor to Amgen and Wyeth trial to evaluate the impact of a tumor necrosis factor (TNF) inhibitor in patients with rheumatoid arthritis (RA) in the United States (RADIUS study). (2002 Drug Week via NewsRx.com and NewsRx.net , Drug Week, November 29) Clinical trial comparing the efficacy of cyclooxygenase 2-specific inhibitors in treating osteoarthritis supported by Pharmacia (Arthritis Rheum. 2003 Nov;48(11):3102-11.) On the Speaker’s Bureau for Abbott, Amgen/Wyeth, Pfizer and TAP Pharmaceuticals. (http://www.fbhc.org/cme/abt04202/index.cfm; accessed 2/23/05) Consultant to Abbott, Amgen/Wyeth and Pfizer. (http://www.fbhc.org/cme/abt04202/index.cfm; accessed 2/23/05) Stockholder: Abbott, Amgen, Bristol Myers-Squibb and Pfizer.(http://www.fbhc.org/cme/abt04202/index.cfm; accessed 2/23/05) Dr. Gibofsky is a member of The Cadeuceus Group, LLC. (http://www.fbhc.org/cme/abt04202/index.cfm; accessed 2/23/05) Charles H. Hennekens, M.D., Visiting Professor of medicine and Epidemiology and Public Health, School of Medicine, University of Miami, Boca Raton, FL. Coinventor on a patent application filed by Brigham and Women’s Hospital on the use of markers of inflammation in coronary artery disease. (N Engl J Med. 2000; 342:836-43) Consultant for AstraZeneca, Bristol-Myers Squibb/Sanofi, Novartis, Pfizer, and Reliant. Co-author of Pfizer funded study, “Absence of Interaction Between Atorvastatin or Other Statins and Clopidogrel.” (Arch Int Med. 2004; 164: 2051-7) Serves as a consultant, including Chair or membership on Data and Safety Monitoring Boards, to AstraZeneca, Bayer, Bristol-Myers Squibb, Chattem, Delaco, Glaxo-Smith Kline, McNeil, Novartis, Pfizer, and Reliant. (Circulation. 2003;108(10):1191-5) Steven E. Nissen, M.D., Vice-chairman of Cardiology, and Head of Clinical Cardiology, Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH. Research on lipid-lowering therapy on progression of coronary atherosclerosis through the use of statins Pravachol (pravastatin) and Lipitor (atorvastatin) funded by Pfizer. Research support from AstraZeneca, Merck-Schering Plough, Esperion Therapeutics, Takeda, Pfizer, and Sankyo. (JAMA. 2004;291:1071-80) Richard Platt, M.D., M.Sc. Professor and Chair, Department of Ambulatory Care and Prevention, Harvard Medical School, Boston, MA. Primary investigator in 9/1/04- 8/31/05 project funded by Pfizer on enhanced identification of adverse drug events. Primary investigator in 9/1/04-8/31/05 project funded by TAP Pharmaceuticals on Gout Pharmacoepidemiology. (http://kpco-cru.org/Biosketch/Raebel%20Marsha.pdf; accessed 2/23/05) Co-investigator of 01/01/03-12/31/05 study funded by GlaxoSmithKline on Safety and Utilization of Lotronex in the United States. (http://kpco- cru.org/Publications/2004-05_Grants_Updated.pdf; accessed 2/23/05) In addition, CSPI found seventeen (17) physician/researchers who received research support or had other financial ties to pharmaceutical firms (but not direct ties to manufacturers of Cox-2 inhibitors). In three cases, the ties were to Merck or Pfizer but were deemed too old to be relevant. They were: Total: 16 Ralph B. D’Agostino, Ph.D., Professor of Mathematics/Statistics and Public Health, Boston University, MA. On the scientific advisory board of Gentium S.p.A. (http://www.sec.gov/Archives/edgar/data/1314755/000104746905001308/a2150064zf- 1.htm; accessed 2/23/05) On scientific advisory board of Penwest. (“Penwest Appoints Pharmaceutical Industry Leaders Dr. William M. Wardell And Dr. Ralph B. D'Agostino to Scientific Advisory Board,” PR NewsWire, 6/8/01) Has interests in pharmaceutical
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